Summary of Product Characteristics
last updated on the eMC:
19/08/2010
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 19/08/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 4.1 - Therapeutic indications
-
Change to section 4.2 - Posology and method of administration
-
Change to section 6.1 - List of Excipients
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
|
| Date of revision of text on the SPC: 01-Mar-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.1: "For the symptomatic relief of mouth and throat infections." replaced "A red circular lozenge"
Section 4.2: Text changed to "
Adults and children (over 6 years old):
One lozenge to be dissolved slowly in the mouth every 2-3 hours up to a maximum of 12 lozenges in 24 hours.
Not suitable for children under 6 years."
Section 6.1: "Solids from liquid sugar demin, (or from liquid sugar T & L T1001) and from liquid glucose, Water (potable)." changed to "Liquid sucrose, Liquid glucose."
Renewal of authorisation
|
|
Updated on 28/07/2010 and displayed until 19/08/2010
|
Reasons for adding or updating:
|
-
New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
|
| Date of revision of text on the SPC: |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| None provided |
|
